Conveen Optima Urisheaths With Collecting Bags Versus Absorbents

Evaluation de l'Impact Sur la qualité de Vie de l'Utilisation d'un système Collecteur Conveen( étuis pénien Conveen Optima Avec Poches de Recueil Conveen) Chez Des Hommes Souffrant d'Une Incontinence Urinaire modérée ou sévère, Comparativement à Leur Protection Absorbante Habituelle

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01056666

Enrollment

Registered

2010-01-26

Start date

2007-06-30

Completion date

2009-03-31

Last updated

2011-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

Brief summary

The objective of this investigation is to asses with validated scales, the impact on the quality of life of men suffering of moderate to severe incontinence of the use of Conveen Optima urisheath in comparison with their usual absorbent protection.

Interventions

DEVICEConveen Optima is a urisheath to be used together with a collecting bag for urine

Conveen optima urisheath is intended to be used together with a collecting bag for urine and to be changed on a daily basis

DEVICEabsorbent protection

The patient use his usual absorbent protection (same brand), and change it when needed

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient over 18 * Out clinic patient * Patient using absorbent protection for his urinary incontinence * Moderate to severe urinary incontinence (1 hour pad test \> 10g) * All kind of stable urinary incontinence * Patient able to apply himself the device * Patient able to understand the questions * Patient having given his informed consent * Patient whose overall treatment for his urinary incontinence is not modified during the study

Exclusion criteria

* Patient having a retracted penis * Patient having skin problem on the penis * Patient using urisheaths * Bedridden patient * Institutionalized patient * Patient with indwelling catheter or under intermittent catheterisation * Patient with fecal incontinence leading to the use of absorbent protection * Patient suffering of urinary tract infection

Design outcomes

Primary

Measure	Time frame
Impact on quality of life	Days 0, 15, 30

Secondary

Measure	Time frame
Efficacy (leakages)	days 13, 14, 15 and days 28, 29, 30

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026